A prospective, controlled, randomized, double blind, comparative, parallel, 2-arms study to evaluate the efficacy and safety of Epalrestat (150 mg) compared to Pregabalin (600 mg) in patients suffering from painful diabetic peripheral neuropathy.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- 1)Primary Efficacy Parameters:
研究概览
简要总结
Prospective, controlled, randomized, double blind, Comparative, parallel, 2-arms study, evaluating and comparing the effects of oral Epalrestat (150mg) compared to Pregabalin (600 mg) in patients suffering from painful diabetic peripheral neuropathy. Patients will be divided into two groups; Group I patients will receive the investigational product Epalrestat (150mg) as oral therapy, Group II patients will Pregabalin (600 mg) orally.
Efficacy parameters:
1) Primary:
a. Pain severity as measured on 11 point Visual Analogue scale (VAS)
b. Modified neuropathy disability score
2) Secondary:
a. Other symptom intensity will be assessed on VAS
b. Relief of Pain / any other symptom will be assessed on VAS
c. Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change
Assessment Schedule:
Efficacy parameters- 0, 30 days, 60 days, 90 days
Safety parameters- 0, 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group between 20 to 70 years.
- •Diabetic patients stabilized on antidiabetic medication (on stable dose of antidiabetic drugs for the last 4 weeks) with stable glycemic control (HbA1c < 9%, with ± 0.5% variation in the previous 3 months) presenting with subjective symptoms of peripheral neuropathy confirmed on the basis Modified neuropathy disability score >
- •Subjects whose pain score of at least 40 mm on the 100 mm visual analogue scale (VAS).
排除标准
- •Patients with stage 3 (N3) i.e. disabling neuropathy or presence of symptoms/ signs of foot ulcer.
- •Patients with diabetic neuropathy requiring hospital admission for management of neuropathy/ diabetic complications / any other disease condition.
- •Patients presenting with primary cause of neurologic disorders other than diabetes (alcoholic neuropathy, carpal tunnel syndrome, sequelae of cerebrovascular disease).
- •Patients with history of or current diagnosis of mania, bipolar disorder, obsessive-compulsive disorder, or posttraumatic stress disorder or to be at risk of suicide judged before randomization.
- •Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.
- •Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
- •Patients with H/O alcohol/ drug abuse.
- •Pregnant and lactating females.
- •Simultaneous participation in another clinical study or if they were receiving other experimental medications for diabetic neuropathy, prostaglandin E1 preparations, or any other medication that affects symptoms of diabetic neuropathy.
结局指标
主要结局
1)Primary Efficacy Parameters:
时间窗: Efficacy parameters- 0, 30 days, 60 days, 90 days
a.Pain severity as measured on 11 point Visual Analogue scale (VAS)
时间窗: Efficacy parameters- 0, 30 days, 60 days, 90 days
b.Modified neuropathy disability score
时间窗: Efficacy parameters- 0, 30 days, 60 days, 90 days
次要结局
- Safety parameters:(1. ADR recording,)
- 2)Secondary Efficacy Parameters:(a. Other symptom intensity will be assessed on VAS)